EUS Guided Liver Biopsy Proposal Titled : EUS Guided Liver Biopsy - Will it Give Better Yield , More Tissue With Less Complication ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Diagnostic yield with EUS guided liver biopsy .
研究概览
简要总结
Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.
详细描述
In this study, we aim to evaluate the tissue adequacy of EUS guided liver biopsy for parenchymal liver disease and to evaluate if diagnostic yield of left lobe is non-inferior to right lobe biopsies and to assess if combination biopsies have better yield than single lobe biopsies. Safety of the procedure and technical success would be noted.
The data would be analysed using SPSS software and needful variables and tests would be used as per statistical requirement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The biopsy specimens would be reported independently by two pathologists who would be masked to the source of tissue ( right/ left lobe ).
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any undiagnosed hepatic disease (after extensive investigation - serological as well as imaging) requiring a liver biopsy
- •Patients of NAFLD who need liver biopsy
- •Alcoholic hepatitis patients needing biopsy
- •Any patient with unexplained transaminesemia > 1.5 times ULN needing a liver biopsy as advised by Hepatologist
排除标准
- •Any liver Space occupying lesion suspicious of malignancy
- •Platelet count <80,000
- •INR > 1.5
- •Pregnancy
- •Severe cardiovascular and pulmonary diseases
- •Recent use of anti-platelet agents within 5 days of the procedure
- •Unwilling to provide informed consent
结局指标
主要结局
Diagnostic yield with EUS guided liver biopsy .
时间窗: 3 days
The diagnostic yield of a right lobe biopsy and left lobe biopsy would be compared to see if right lobe biopsy gives any additional information for diagnosis when compared to left lobe .
次要结局
- Safety of procedure(3 days)
- Post procedural complications(3 days)
- NAS score in fatty liver patients(3 days)
- Duration of procedure(30 minutes)
- Size of tissue acquired(3 days)
- Number of portal tracts(3 days)
- Patient recovery time(3 days)
研究者
Dr Mithun Sharma
Consultant Hepatologist
Asian Institute of Gastroenterology, India